To make the regulations of the recently amended Drugs & Cosmetics Rules related to medical devices more clear, experts urged the government to make some important changes in the same at the earliest. Industry insiders stressed that while the amendment does address some issues, like qualification of technical persons etc., it fails to clarity important topics like product identification, printing of import licence number etc.

On September 25 the health ministry through a notification amended the D&C Rules relating to medical devices. What took the industry by surprise is the amendment of the rule 109A of the D&C Rules to make labelling of medical devices mandatory in the country, which albeit a thoughtful idea fails to get the intended result due to string of loopholes in the amended provisions.

Further, the Association of Indian Medical Device Industry (AIMED) informed that there is a lot of confusion among industry members over the reference of CI. 7schedule R-1 which refers to international pharmacopoeia standards. This is mainly because medical devices which are not considered drugs under the Act may also be confused with the same by regulators in the lack of clarification by the Centre on the same, especially since, medical devices usually confer with IS/ISO product standards, said Rajiv Nath, forum coordinator of AIMED.

In the light of these events, the Association recently made a strong point to the health ministry last weak urging them to either delete the reference of international pharmacopoeia standards from the same or qualify it as international pharmacopoeia standards only for devices containing drugs to avoid confusion.

Among the other suggestions the Association urged the government to also amend Rule 109 A, to incorporate labelling of units packs as well along with shelf pack to ensure free and fair competitive ground for all.